Clinical efficacy and safety: Nervous system

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This page lists the European Medicines Agency's scientific guidelines on the clinical safety and efficacy of medicines used in nervous-system disorders. 

If you have comments on a document which is open for consultation, use the form for submission of comments on scientific guidelines.

Please note that the Efficacy Working Party secretariat e-mail address (ewpsecretariat@ema.europa.eu) no longer exists. Therefore, please submit your comments from now on to the following e-mail address: cnswpsecretariat@ema.europa.eu.

TopicDocumentsReference numberPublication dateEffective dateRemarks
Guideline on the clinical development of medicinal products for the treatment of Autism Spectrum Disorder (ASD)Draft guidelineEMA/CHMP/598082/2013Released for consultation 4 March 2016 End of consultation 31 August 2016
Need for revision of the guideline on medicinal products for the treatment of Alzheimer's disease and other dementias

Draft guideline

Concept paper

EMA/CHMP/539931/2014Released for consultation 1 Feb 2016 End of consultation 31 Jul 2016
Concept paper on no need for revision of the guideline on medicinal products for the treatment of Alzheimer's
disease and other dementias
Concept paperCHMP/60715/2012March 2012  
Medicinal products for the treatment of Alzheimer's disease and other dementias

Adopted guideline

Draft guideline

Concept paper

CPMP/EWP/553/1995 revision 1July 2008February 2009 
Clinical development of medicinal products intended for the treatment of painDraft guidelineEMA/CHMP/970057/2011Released for consultation 21 December 2015 End of consultation 31 March 2016
Clinical development of medicinal products intended for the treatment of painDraft guidelineEMA/CHMP/970057/2011Released for consultation May 2013 End of consultation 30 November 2013
Development of medicinal
products for the treatment of autism-spectrum disorder
Concept paperEMA/CHMP/40896/2013Released for consultation April 2013 End of consultation 4 July 2013
Clinical investigation of medicinal products for the treatment of Duchenne and Becker muscular dystrophy

Overview of comments

Adopted guideline

Draft guideline

Concept paper

EMA/CHMP/236981/2011December 20151 July 2016 
Clinical investigation of medicinal products for the treatment of multiple sclerosis

Adopted guideline

Draft guideline

CHMP/771815/2011 Rev. 2March 20151 October 2015 
Need for revision of guideline on clinical investigation of medicinal products for the treatment of multiple sclerosisConcept paperCHMP/CNSWP/257565/2011Released for consultation June 2011 End of consultation 30 September 2011
Clinical investigation of medicinal products for the treatment of multiple sclerosis

Overview of comments

Adopted guideline

Draft guideline

CHMP/EWP/561/1998 Rev. 1November 2006June 2007 
Clinical investigation of medicinal products, including depot preparations in the treatment of schizophrenia

Overview of comments

Adopted guideline

Draft guideline

Concept paper

CHMP/40072/2010 Rev. 1October 20121 April 2013 
Clinical investigation of medicinal products in the treatment of schizophreniaAdopted guidelineCPMP/EWP/559/1995February 1998August 1998 
Need for revision of the appendix to the note for guidance on the clinical investigation of medicinal products in the treatment of schizophrenia – methodology of clinical trials concerning the development of depot preparations of approved medicinal products in schizophreniaConcept paperCHMP/457223/2011October 2011September 2011 
Clinical investigation of medicinal products in the treatment of depression

Adopted guideline

Draft guideline

Concept paper

CHMP/185423/2010 Rev. 2May 2013December 2013 
Clinical investigation of medicinal products in the treatment of depressionAdopted guidelineCPMP/EWP/518/1997 Rev. 1April 2002October 2002 
Treatment of premenstrual dysphoric disorder

Overview of comments

Adopted guideline

Draft guideline

Concept paper

CHMP/607022/2009August 2011 February 2012 
Development of medicinal products for the treatment of alcohol dependence

Overview of comments

Adopted guideline

Draft guideline

CHMP/EWP/20097/2008March 2010September 2010 
Clinical investigation of medicinal products for the treatment of attention-deficit / hyperactivity disorder

Overview of comments

Adopted guideline

Draft guideline

Concept paper

CHMP/EWP/431734/2008July 2010February 2011 
Medicinal products for the treatment of insomnia

Overview of comments

Adopted guideline

Draft guideline

Concept paper

CHMP/16274/2009February 2011September 2011 
Medicinal products for the treatment of insomnia

Adopted guideline

3CC27A March 1992 
Need for revision of note for guidance on clinical medicinal products for treatment of nociceptive pain and guideline on clinical investigation of products intended for the treatment of neuropathic painConcept paperCHMP/210477/2011Released for consultation September 2011 End of consultation 31 December 2011
Clinical medicinal products intended for the treatment of neuropathic pain

Overview of comments

Adopted guideline

Draft guideline

CPMP/EWP/252/2003 Rev. 1February 2007July 2007 
Clinical investigation of medicinal products for treatment of nociceptive painAdopted guidelineCPMP/EWP/612/2000November 2002May 2003 
Clinical investigation of medicinal products for treatment of migraine

Overview of comments

Adopted guideline

Draft guideline

CPMP/EWP/788/2001 Rev. 1February 2007July 2007 
Development of medicinal products for the treatment of post-traumatic stress disorder

Overview of comments

Adopted guideline

Draft guideline

Concept paper

CHMP/EWP/358650/2006 corrigendum 2October 2008February 2009 
Clinical investigation of medicinal products indicated for the treatment of social anxietyAdopted guidelineCHMP/EWP/3635/2003January 2006August 2006 
Development of new medicinal products for the treatment of smoking

Overview of comments

Adopted guideline

Draft guideline

Concept paper

CHMP/EWP/369963/2005January 2009July 2009 
Clinical investigation of medicinal products indicated for generalised anxiety disorderAdopted guidelineCPMP/EWP/4284/2002January 2005July 2005 
Clinical investigation of medicinal products indicated for panic disorderAdopted guidelineCHMP/EWP/4280/2002January 2005July 2005 
Clinical investigation of medicinal products for the treatment of obsessive compulsive disorderAdopted guidelineCHMP/EWP/4279/2002January 2005July 2005 
Appendix to the Committee for Proprietary Medicinal Products (CPMP) note for guidance on the clinical investigation of medicinal products in the treatment of schizophrenia, on the methodology of clinical trials concerning the development of depot preparations of approved medicinal products in schizophreniaAdopted guidelineCPMP/EWP/49/2001February 2003August 2003 
Points to consider on clinical investigation of medicinal products for the treatment of acute strokeAdopted guidelineCPMP/EWP/560/1998September 2001April 2002 
Clinical investigation of medicinal products for the treatment and prevention of bipolar disorderAdopted guidelineCPMP/EWP/567/1998April 2001October 2001 
Clinical investigation of medicinal products in the treatment of epileptic disorders

Overview of comments

Adopted guideline

Draft guideline

Concept paper

CPMP/EWP/566/1998 Rev. 2 Corr.January 2010August 2010 
Clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis

Overview of comments

Adopted guideline

Draft guideline

Concept paper

EMA/531686/2015December 20151 June 2016 
Points to consider on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosisAdopted guidelineCPMP/EWP/565/1998October 2000May 2001 
Clinical investigation of medicinal products in the treatment of Parkinson's disease

Adopted guideline

Questions and answers on additional clarification for inclusion criteria

Overview of comments

Adopted guideline

Draft guideline

Concept paper

CHMP/330418/2012 Rev. 2July 2012July 2012 

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